2,365 results · 18ms · Sources: EU EUDAMED, US FDA

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NeuroPace RNS System

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·PARADIGM REAL-TIME INSULIN PUMP

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·TMX-2000 BPH THERMOTHERAPY SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·CONSTANT FLOW IMPLANTABLE INFUSION PUMP

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP, Impella RP with SmartAssist

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Precision Spinal Cord Stimulator (SCS) Systems

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS Eyhance™ IOL with TECNIS Simplicity™ Delivery System, Model DIB00, TECNIS Eyhance™ Toric II IOLs with TECNIS Simp

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·LIVEWIRE TC ABLATION CATHETER

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·Wave Light EX500 Laser

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval
FDA Class 3 ·Vercise Gevia Deep Brain Stimulation (DBS) System

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·FLAIR ENDOVASCULAR STENT GRAFT

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·SenSight™ Directional Lead Kit

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval
FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) Systems

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Restore, Itrel, Synergy, and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Restore, Itrel®, Synergy® and Intellis Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectris® Spinal Cord S

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval
FDA Class 3 ·CARDIOGENESIS TMR SYSTEM

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·Wave Light EX500 Laser

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·ENLITE GLUCOSE SENSOR, ENLITE SERTER